FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3063352
·
Received April 17, 2013
Report
- Report Number
- 3007566237-2013-01323
- Event Type
- Injury
- Date Received
- April 17, 2013
- Date of Event
- March 27, 2013
- Report Date
- November 8, 2023
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, FR
- Reporter Occupation
- HEALTH PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3877, IMPLANTED: 2012-(B)(6). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED PAIN. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 OHMS. IT WAS NOT POSSIBLE TO PROGRAM THE LEAD ANYMORE. THE PATIENT WILL NEED TO HAVE SURGICAL INTERVENTION TO ANALYSIS THE CAPACITY OF THE LEAD AND EXTENSION. SURGERY WAS NOT SCHEDULED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEAD WOULD BE CHANGED ON (B)(6)-2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165441 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Male | Required Intervention | "SEE H10...." |